Eisai Resubmits Fycompa® (perampanel) to German Federal Joint Committee for Additional Benefit Assessment

 Eisai Resubmits Fycompa® (perampanel) to German Federal Joint Committee for
                        Additional Benefit Assessment

  PR Newswire

  HATFIELD, England, May 12, 2014

HATFIELD, England, May 12, 2014 /PRNewswire/ --

 Early resubmission positive step forward for first-in-class epilepsy drug in

Eisai has resubmitted its first-in-class epilepsy treatment Fycompa ^®
(perampanel) to the German Federal Joint Committee (G-BA) for reassessment of
its additional therapeutic benefits. This follows the G-BA decision in
February that Eisai could resubmit their anti-epileptic drug (AED) for early
reassessment. The new decision is expected to be published within 6 months.
Perampanel is indicated for the adjunctive treatment of partial onset
seizures, with or without secondarily generalised seizures, in people with
epilepsy aged 12 years and older. ^[1] 

"We are very pleased that the G-BA has approved our request for an early
benefit reassessment of Fycompa," commented Gary Hendler, President & CEO,
Eisai EMEA. "The clinical benefit of Fycompa has been recognised in
approximately 3,000-4,000 people with epilepsy in Germany since its launch in
September 2012 and our first concern throughout this process has been for
them. We firmly believe that innovative treatment options are desperately
needed for people with this serious condition and believe that the G-BA will
reconsider its original position and not effectively deny very ill patients
the clinical benefit that Fycompa offers people with partial epilepsy again."

Eisai temporarily suspended perampanel from distribution in Germany (Aussetzen
des Vertriebes) in June 2013 following the previous negative G-BA ruling and
established a programme for continued supplyof perampanel (Fycompa) free of
charge to German pharmacies through individual import (managed by Clinigen
Group plc) to ensure that people with epilepsy continue to receivetreatment
with perampanel (Fycompa), whilst the G-BA consider the resubmission.

"There still remains a very high need for effective new treatments to reduce
seizures in patients with refractory partial epilepsy in Germany. The early
resubmission of Fycompa for benefit reassessment is a positive step forward as
it means that doctors and patients may soon be able to access a treatment
option with proven clinical benefits through the usual way of distribution,"
commented Professor Bernhard Steinhoff, from Epilepsiezentrum Kork, Kehl-Kork,

In Germany, approximately one in every 200 people has epilepsy, which equates
to an estimated 400,000 people in the country who live with the condition.
^[2] Epilepsy is one of the most common neurological conditions in the world.
^[3] The successful treatment of partial onset seizures remains a challenge as
over 30% of patients do not achieve seizure freedom despite appropriate
therapy with AEDs. ^[4]

Discovered and developed by Eisai in the UK and Japan, perampanel is the first
and only approved AED in Europe with a mode of action that selectively targets
AMPA receptors, thought to play a central role in seizure generation and
spread. ^[5]

Eisai is a leading research and development based pharmaceutical company. The
company's Corporate Philosophy is to give first thought to patients and their
families, and to increase the benefits that health care provides to them.
Eisai calls this philosophy human health care ( hhc ). Eisai believes that the
hhc philosophy is its primary objective and that only through focussing on the
needs of the patient and the wider global healthcare system that sales and
earnings will be generated. Guided by our hhc philosophy, Eisai will continue
to work to achieve sustainable enhancement of value through its business
activities worldwide.

Notes  to  Edi to rs 

About Perampanel 

Perampanel is licensed in the European Union (EU) as an adjunctive treatment
for people aged 12 years and older with partial-onset seizures, with or
without secondarily generalised seizures. ^[1 ^]

Perampanel is a highly selective, non-competitive AMPA
(alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate
receptor antagonist that has demonstrated seizure reduction in Phase II and
III studies. AMPA receptors, widely present in almost all excitatory neurons,
transmit signals stimulated by the excitatory neurotransmitter glutamate
within the brain and are believed to play a role in central nervous system
diseases characterised by excess neuroexcitatory signalling including
epilepsy, neurodegenerative disorders, movement disorders, pain and
psychiatric disorders. ^[1 ^]

Further information for healthcare professionals can be found at

About Perampanel in Germany 

Recently, the first multicenter practical experience with Perampanel in a
larger series of consecutive patients with difficult-to-treat epilepsies from
9 specialized hospitals from Germany (7 centers) and Austria (2 centers) have
been published. ^[6] Patients (54% female, mean age 38 years) were followed-up
for treatment outcome for a minimum of 6 months. In half of the n=281 patients
included, who received Perampanel mostly as add-on to a baseline therapy
consisting of 2 or 3 AEDs (65%), seizure frequency was reduced by at least
50%. Seizure freedom was achieved in 15% of patients. Adverse events were
reported by 52% of patients, with somnolence (24.6%) and dizziness (19.6%)
being most frequently reported. The retention rate after 6 months was 60%. The
mean Perampanel dosage was 7.7 mg. In some patients, a marked response could
be observed at relatively low dosages, which is mooted by the authors as
possibly pointing to a special sensitivity of those patients to the new
mechanism of action of Perampanel. The authors award Perampanel some
encouraging potential as an add-on AED in their conclusion.

About Epilepsy 

Epilepsy is one of the most common neurological conditions in the world,
affecting approximately one in every one hundred people in Europe, and an
estimated 50 million people worldwide. ^[7] ^, ^[8] Epilepsy is a chronic
disorder of the brain that affects people of all ages. It is characterised by
abnormal discharges of neuronal activity causing seizures. Seizures can vary
in severity, from brief lapses of attention or jerking of muscles, to severe
and prolonged convulsions. Depending on the seizure type, seizures may be
limited to one part of the body, or may involve the whole body. Seizures can
also vary in frequency from less than one per year, to several per day.
Epilepsy has many possible causes but often the cause is unknown.

About Eisai EMEA in Epilepsy 

Eisai is committed to developing and delivering highly beneficial new
treatments to help improve the lives of people with epilepsy. The development
of AEDs is a major strategic area for Eisai in Europe, the Middle East,
Africa, Russia and Oceania (EMEA).

In the EMEA region, Eisai currently has four marketed treatments including:

  *Fycompa ^® (perampanel) for use as an adjunctive treatment for partial
    onset seizures, with or without secondarily generalised seizures, in
    patients with epilepsy aged 12 years and older
  *Inovelon ^® (rufinamide) for the adjunctive treatment of seizures
    associated with Lennox-Gastaut Syndrome in patients > 4 years. (Inovelon
    was originally developed by Novartis)
  *Zebinix ^® (eslicarbazepine acetate) as adjunctive therapy in adult
    patients with partial onset seizures, with or without secondary
    generalisation. (Zebinix is under license from BIAL)
  *Zonegran ^® (zonisamide) as monotherapy in adults and adjunctive therapy
    in adults, adolescents and children aged six years and above with partial
    onset seizures, with or without secondary generalisation. (Zonegran is
    under license from the originator Dainippon Sumitomo Pharma)

About Eisai 

Eisai is one of the world's leading research and development (R&D) based
pharmaceutical companies and we define our corporate mission as "giving first
thought to patients and their families and to increasing the benefits health
care provides," which we call human health care ( hhc ).

Eisai concentrates its R&D activities in three key areas:

  *Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight
  *Oncology including: anticancer therapies; tumour regression, tumour
    suppression, antibodies, etc.
  *Vascular/Immunological reaction including: thrombocytopenia, rheumatoid
    arthritis, psoriasis, inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of
Japan, Eisai employs more than 10,000 people worldwide. From its EMEA
Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business
operations to include Europe, the Middle East, Africa, Russia and Oceania
(EMEA). Eisai EMEA has sales and marketing operations in over 20 markets,
including the United Kingdom, Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Ireland, Italy, Norway, Portugal, Russia, Slovakia,
Spain, Switzerland, Sweden, the Netherlands and the Middle East.

For further information please visit our web site http://www.eisai.co.uk


1. Fycompa. Summary of Product Characteristics (updated November 2013)

2. Pfäfflin, M. und May, T. Wieviele Patienten mit Epilepsien gibt es in
Deutschland und wer behandelt sie? Neurol Rehabil, 2000; 6, (2) 77-81. 

3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care
in Europe 2010. Available at;
http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf (Accessed
June 2011) 

4. Brodie MJ et al, Neurology 2012; 78:1548-1554 

5. Rogawski MA. Epilepsy Currents 2011;11:56-63 

6. Steinhoff, B.J., et al., A multicenter survey of clinical experiences with
perampanel in real life in Germany and  

Austria. Epilepsy Res. (2014),

7. Epilepsy in the WHO European Region 
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed 10
April 2012].

8. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224 - 2233. 

Date of preparation: May 2014

Job code: Perampanel-UK2157

Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte
Andrews, +44(0)7908-314-155/+44(0)7947-231-513, Cressida_Robson@eisai.net,
Charlotte_Andrews@eisai.net ; Tonic Life Communications, Frances Murphy/Nicola
Lilley, +44(0)207-798-9262 /+44(0)207-798-9905, frances.murphy@toniclc.com,
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